The Food and Drug Administration (FDA) has granted Orphan Drug Designation to a novel treatment for the progressive inflammatory condition bronchiolitis obliterans in post-lung transplant patients.
Bronchiolitis obliterans is the leading cause of morbidity and mortality in the pulmonary transplant population with ≥50% of patients who receive a lung transplant developing the condition within 5 years. It can also occur following hematopoietic stem cell transplantation and after exposure to certain chemicals. The condition results in airflow obstruction and loss of function in the lung.
The investigational treatment OSP-101 is an interleukin-1 (IL-1) receptor antagonist that is delivered by inhalation directly to the lung; IL-1 plays a key role in chronic inflammation in the lung. The treatment is also being evaluated as a possible therapy for idiopathic pulmonary fibrosis, cystic fibrosis, and other causes of bronchiolitis obliterans.
We are very pleased that FDA granted Orphan Drug Designation to OSP-101 for the treatment of bronchiolitis obliterans,” said Brian Lortie, President and CEO of Onspira Therapeutics. “This is a significant milestone for Onspira, and we look forward to advancing the clinical program in coordination with the FDA and our advisors.”
For more information visit Onspira.com.